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OpenTrials
Completed

NCT Number: NCT04377958

Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma

Serum samples of asthmatic patients will be screened for serum biomarkers

Completed

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Key information

Conditions

Asthma Biomarkers Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 - 65 years
  • physician-diagnosed asthma

Exclusion criteria

  • No clear asthma phenotype
  • Presence of other pulmonary diseases (Chronic obstructive pulmonary disease, alfa-1-antitrypsine deficiency emphysema, Immunoglobulin E deficiency, allergic bronchopulmonary aspergillosis)
  • > 15 pack years
  • No sputum available
  • Respiratory infection
  • Other inflammatory diseases (Rheumatoid Arthritis, Colitis Ulcerosa)

Treatment and study plan

Serum biomarker testing

Diagnostic Test

Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA

Primary outcomes

  1. Serum calprotectin

    Time frame: Day 1

    Serum Calprotectin (pg/ml) will be measured in serum samples using a U-plex assay

Secondary outcomes

  1. Sputum calprotectin

    Time frame: Day 1

    Sputum Calprotectin (pg/ml) will be measured in sputum samples using a U-plex assay

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
May 7, 2020
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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